FDA 510(k) Application Details - K013513

Device Classification Name Arthroscope

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510(K) Number K013513
Device Name Arthroscope
Applicant PAIN CONCEPTS, INC.
8001 IRVINE CENTER DR.
4TH FLOOR
IRVINE, CA 92618 US
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Contact RUSSELL PFLUEGER
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 10/22/2001
Decision Date 01/17/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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